Key Points:
- On April 1, 2024, the U.S. Department of Health and Human Services (HHS) issued new guidance requiring hospitals to obtain informed consent from patients before certain procedures and examinations are performed by practitioners, students, or trainees. This includes rectal examinations and other sensitive or invasive procedures.
- Hospitals are now mandated to establish clear guidelines ensuring that healthcare providers and trainees obtain proper informed consent from patients before conducting sensitive examinations. Documentation of this consent must be recorded in the patient’s medical record.
- The requirement applies to both inpatient and outpatient settings, covering procedures performed on hospital patients. The Centers for Medicare & Medicaid Services (CMS) particularly stress the importance of informed consent for procedures performed under anesthesia, including disclosure of who will be conducting the procedure and its purpose, as well as the patient’s right to refuse consent for procedures conducted for teaching purposes.